跳至主要内容
临床试验/CTRI/2025/02/080826
CTRI/2025/02/080826招募中2 期

Evaluate the efficacy of cold compress to eye on tear production and OSDI score in keratoconjunctivitis sicca - A Randomized control trial

Dr N Sheerin Izzath1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Schirmer’s test I score, Ocular Surface Disease Index

研究概览

简要总结

Keratoconjunctivitis sicca, commonly known as dry eye syndrome, is a highly prevalent condition affecting 5-55% of the global population. It is often underdiagnosed and can significantly impact daily life activities such as reading, writing, and driving. Dry eye syndrome is characterized by loss of homeostasis of the tear film, leading to ocular symptoms, inflammation, and damage.

The condition can be classified into two groups: evaporative dry eye and aqueous deficiency dry eye. Intrinsic factors contributing to dry eye disease include increasing age, female gender, and certain autoimmune conditions. Extrinsic factors, such as digital screen use, contact lens wear, and environmental factors, also play a significant role. Symptoms of dry eye disease include ocular dryness, discomfort, pain, grittiness, foreign body sensation, visual abnormalities, and redness.

This study aims to evaluate the efficacy of cold compress treatment in patients with keratoconjunctivitis sicca. Cold compress is a hydrotherapy treatment method that improves blood circulation, reduces inflammation, and promotes relaxation. Although it has been used in various ocular conditions, there is a lack of evidence in dry eye disease. This study will assess the impact of cold compress treatment on tear production, OSDI score, and visual acuity in patients with dry eye syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients who have Schirmer’s test one score less than ten millimetres in five minutes.
  • Patients who can differentiate Hot and Cold.
  • Patients who are willing to give consent.

排除标准

  • Patients with defects of eyelid or eyelashes.
  • Past history of surgical eye operations in the last three months.
  • Eyeball or ocular appendage injuries.
  • Active ocular infections.
  • Taking systemic corticosteroids or immunosuppressant treatment.

结局指标

主要结局

Schirmer’s test I score, Ocular Surface Disease Index

时间窗: Schirmer’s test I score and Ocular Surface Disease Index will be assessed at baseline and after 4 weeks of intervention.

次要结局

  • Visual acuity test(Visual acuity test will be assessed using the Snellens chart at baseline & after 4 weeks of intervention.)

研究者

发起方
Dr N Sheerin Izzath
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr N Sheerin Izzath

International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu

研究点 (1)

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